Valves are important structures in the human heart because they maintain blood flow in a single direction with minimal pressure loss. However, human heart valves can degenerate for a variety of reasons. For example, a malfunctioning heart valve may be stenotic, where the leaflets of the valve do not open fully, or the valve may be regurgitant, where the leaflets of the valve do not close properly, or a combination of both. Valve repair and replacement procedures have thus been developed to either restore the function of the native valves or to implant a permanent prosthetic valve with or without removal of the original native valve. The standard surgical procedure involves the opening of the patient's thoracic cavity, which is highly invasive and requires cardiopulmonary bypass and a prolonged recovery time.
Percutaneous valve repair and replacement procedures have been developed as cheaper and safer substitutes for traditional open chest surgeries. Compared to traditional surgery, a percutaneous valve repair procedure is minimally invasive and eliminates the need for cardiopulmonary bypass. In the absence of cardiopulmonary bypass, the percutaneous procedure must take place quickly to restore normal circulation, because native valve function is interrupted during the repair or the positioning and implantation of the permanent prosthetic valve. A temporary valve is a useful tool to, in one respect, maintain unidirectional blood flow during the percutaneous procedure before the permanent prosthetic valve is implanted and/or operational. Further, a temporary valve may be useful during a balloon aortic valvuloplasty (BAV) procedure in which the native valve is dilated with a balloon and which occasionally causes harm to one or more of the native valve leaflets. The temporary valve may serve to replace the function of the one or more native valve leaflets damaged during the BAV procedure. BAV procedures may be stand-alone (e.g., in which no prosthesis is implanted) or may precede percutaneous prosthetic valve implantations either immediately or by a period of several hours, days or weeks.
Therefore, a need exists for a device that can maintain blood flow in a single direction during, e.g., a percutaneous valve repair or replacement procedure and may be removed without causing trauma to the vessel or unduly increasing the time or effort needed to complete the procedure.